BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4123334 · Received September 26, 2014

    Report

    Report Number
    2032227-2014-29516
    Event Type
    Malfunction
    Date Received
    September 26, 2014
    Date of Event
    August 27, 2014
    Report Date
    August 28, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENTLY, IT IS UNKNOWN WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT AS NO PRODUCT HAS BEEN RETURNED. NO CONCLUSION CAN BE DRAWN AT THIS TIME. WE THEREFORE CONSIDER THIS REPORT COMPLETE TO THE BEST OF OUR KNOWLEDGE. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE INSULIN PUMP ALARMED NO DELIVERY, TWICE, THE NIGHT PRIOR TO THE PHONE CALL. THE CUSTOMER'S BLOOD GLUCOSE WAS 168 MG/DL. THE CALLER STATED THAT THE FIRST TIME THE ALARM OCCURRED, THEY CHANGED THE RESERVOIR AND THE SECOND TIME THEY CHANGED THE SITE OF INFUSION SET INSERTION FROM THE CUSTOMER'S LEG TO THEIR BELLY. THE CUSTOMER WAS A NEW INSULIN PUMP USER AND THEY HAD SOME PROBLEMS WITH CONNECTING THE INFUSION SET TO THE RESERVOIR AND LOCKING THE RESERVOIR TO THE INSULIN PUMP. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    602861 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-723NAB

    Patients

    Seq Age Sex Outcome Treatment
    1 11 YR